Swissmedic has carefully examined the indication-extension application submitted by Pfizer on 7 May 2021. Swissmedic is extending the temporary ordinary authorisation of the Pfizer/BioNTech coronavirus vaccine to include young people aged between 12 and 15.
Swissmedic approves indication extension for Comirnaty® for 12 to 15-year-olds
Swissmedic reviewed the application for extension in an accelerated rolling procedure. The results of the ongoing study of the vaccine in young people were submitted and evaluated. As for persons aged 16 and over, the vaccine must be administered in two doses. The vaccine showed around 100 percent efficacy in the clinical trial for the investigated age group. The young trial participants received the same dose as adults, and the immune response was comparable with that of the older trial participants (16 to 25-year-olds). The side effects in the young people also corresponded to the adverse reactions reported in clinical trials with 16 to 25-year-olds and adults. The most frequent ones were pain at the injection site, fatigue, headache, shivering, muscle pain, fever and joint pain. The side effects usually lasted between one and three days, and may be more pronounced after the second dose.